Pharmacist-Led Treat-to-Target Urate Lowering Therapy in Patients With Gout

This project will quantify and compare the effects of a pharmacist-led telehealth-delivered intervention versus usual care on arthritis flare burden and serum urate goal achievement in 310 U.S. Veterans with gout enrolled from five VA medical centers. The project will quantify the effects of the intervention on patient-reported outcomes (improvements in health-related quality of life, pain interference, and participant global assessment).

• Pharmacist-Led (Other): Pharmacist will conduct regular telehealth visits with Veterans during dose escalation phase of gout treatment

Primary outcomes

• flare occurrence [during year two]: The occurrence of two or more flares during year 2.
• serum urate at goal [at end of year one]: Achievement of serum urate <6 milligrams per deciliter (mg/dL) at end of year one.

Secondary outcomes

• Veterans RAND 12 (VR-12) [Baseline visit, Months 6, 12, 18, and 24]: Quality of life instrument to assess components of physical and mental health. The survey asks about a patient's views on their health. The information will keep track of how a patient feels and how well they are able to do their usual activities. Scores include ranking their health from excellent to poor, whether physical or emotional health or pain limits activities or accomplishments, whether their health interferes with social activities and lastly asks patients to compare their physical and emotional health to one year ago. The scales range from not-at-all through all the time.
• Patient Reported Outcomes Measurement Information System (PROMIS) [Baseline visit, Months 6, 12, 18, and 24]: Survey to assess pain on relevant aspects of a patient's life within the last 7 days. The survey asks whether or not pain interfered with enjoyment, concentration, outside-of-home tasks, and socialization. The scale is at a not at all (1) through very much (5).
• Gout-related patient global assessment [Baseline visit, Months 6, 12, 18, and 24]: Participants will complete a rating scale on all the ways gout affects them on a 0-100 scale ranging from very well to very poor.

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* US Veterans with physician-diagnosed
* Documented hyperuricemia (SU > 6.8 milligrams per deciliter)
* Satisfy American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) gout classification criteria
* Report 1 or more flares in the prior 6 months
* Receipt of a new urate-lowering therapy (ULT) prescription (allopurinol or febuxostat) initiated by a primary care provider or longer term ULT but otherwise satisfy the flare/SU criteria

Exclusion Criteria:

* Any patient intolerant or unable to take urate-lowering therapies (allopurinol or febuxostat)
* Patients with a rheumatology encounter within the prior 3 months
* Patients on an allopurinol dose > 300 or a Febuxostat dose > 40
* Patients with stage IV/V Chronic Kidney Disease (CKD)
* Patients with a life expectancy < 12 months
* Patients with a concomitant medication of azathioprine or 6-MPC (urate-lowering therapy contraindicated)

• Ted R. Mikuls, Principal investigator, Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE

NIH grants: I01CX002995